Tag Archives: undertaken

======================================GlaxoSmithKline======================================$3 BILLION——————————————————————7/2/2012——————————————————————(4/1998 – 8/2003)
——————————————————————United StatesallegesGSKparticipated inpreparing
publishing
distributingmisleading medical journal article that misreported that clinical trial of drug demonstrated efficacy in treatment when study failed to demonstrate efficacy
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At same time, United Statesalleges, GSKdidn’t make available data from 2 other studies in which drug also failed to demonstrate efficacy
——————————————————————(2001 – 2007)
——————————————————————United StatesallegesGSKfailed to include certain safety data about drug in reports to FDA meant to allow FDA to determine if drug continues to be safe for approved indications and to spot drug safety trends
——————————————————————missing information included data regarding certain post-marketing studies
——————————————————————data regarding 2 studies undertaken in response to European regulators’ concerns about safety of drug
——————————————————————United StatesallegesGSKstated drug had positive cholesterol profile despite having no well-controlled studies to support that message======================================

======================================Johnson & Johnson (J&J) and subsidiaries, Janssen Pharmaceuticals Inc. and Scios Inc.
Janssen Pharmaceutica Products, L.P.======================================$2.2 BILLION +——————————————————————11/4/2013, Monday——————————————————————Johnson & Johnson (J&J) and Janssen
——————————————————————complaint allegesJ&J and Janssen were aware drug posed serious health risks, but companies downplayed these risks
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For example, whenJ&Jstudy of drug showed significant risk of strokes and other adverse events in patients, complaint alleges Janssencombined study data with other studies to make it appear there was lower overall risk of adverse events
——————————————————————year afterJ&Jreceived results of 2nd study confirming increased safety risk for patients taking drug, but hadn’t published data, one physician who worked on study cautionedJanssen
——————————————————————“[a]t this point, so long after [the study] has been completed … we must be concerned that this gives the strong appearance that Janssen is purposely withholding the findings.”
——————————————————————complaint allegesJanssenknew patients taking drug had increased risk, but nonetheless promoted drug as “uncompromised by safety concerns”
——————————————————————WhenJanssenreceived initial results of studies indicating drug posed same risk as other antipsychotics, complaint alleges company retained outside consultants to re-analyze study results and ultimately published articles stating drug was actually associated with lower risk
——————————————————————J&J and another of its subsidiaries, Scios Inc.
——————————————————————8/2001 – FDA approved drug to treat patients with acutely decompensated congestive heart failure who have shortness of breath at rest or with minimal activity
——————————————————————approval based on study involving hospitalized patients experiencing severe heart failure who received infusions of drug over average 36-hour period
——————————————————————complaint allegedScioshad no sound scientific evidence supporting medical necessity of outpatient infusions and misleadingly used small pilot study to encourage serial outpatient use of drug======================================

======================================Abbott Laboratories Inc.======================================$1.5 BILLION——————————————————————5/7/2012, Monday——————————————————————(2001 – 2006)
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company marketed drug in combination with atypical antipsychotic drugs even after its clinical trials failed to demonstrate adding drug was any more effective than atypical antipsychotic alone for that use
——————————————————————1999 – forced to discontinue clinical trial of drug due to increased incidence of adverse events, including
somnolence
dehydration
anorexiaexperienced by study participants administered drug
——————————————————————funded 2 studies of use of drugboth failed to meet main goals established for the study
——————————————————————When 2nd study failed to show statistically significant treatment difference between antipsychotic drugs used in combination with drug and antipsychotic drugs alone, waited nearly 2 years to notify sales force about study results and another 2 years to publish results======================================

======================================AstraZeneca LP / AstraZeneca Pharmaceuticals LP======================================$520 MILLION——————————————————————4/27/2010, Tuesday——————————————————————engaged doctors to conduct studies on unapproved uses of drug
——————————————————————recruited doctors to serve as authors of articles that were ghostwritten by medical literature companies and about studies doctors in question didn’t conduct
——————————————————————then usedstudies
articlesas basis for promotional messages aboutunapproved uses of drug======================================REFERENCE:======================================11/26/2013 – United States Department of Justice (DOJ) versus BIG Pharma: BIG Pharma fought the law, and the law won ?:
——————————————————————https://stanislawrajmundburzynski.wordpress.com/2013/11/26/united-states-department-of-justice-versus-big-pharma-big-pharma-fought-the-law-and-the-law-won/
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